FDA Adverse Event Injury Summary report: N

KIT IMPLANTABLE SLIM TIP LEAD, 50CM

MDR report key: 16812059 · Received April 25, 2023

Report

Report Number: 1627487-2023-01897
Event Type: Injury
Date Received: April 25, 2023
Date of Event: March 31, 2023
Report Date: April 25, 2023
Manufacturer: ABBOTT MEDICAL
Product Code: PMP
UDI-DI: 05415067027153
PMA / PMN Number: P150004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

DATE OF EVENT IS ESTIMATED. THE ALLEGATION IS AGAINST 1 OF 4 LEADS; HOWEVER, IT IS UNKNOWN WHICH LEAD, THEREFORE, ALL POTENTIAL COMPONENTS ARE BEING LISTED. ADDITIONAL COMPONENTS POTENTIALLY INVOLVED IN THE EVENT INCLUDE: COMMON DEVICE NAME: 50CM IMPLANT LEAD KIT, SLIM TIP, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 7791320. COMMON DEVICE NAME: 50CM IMPLANT LEAD KIT, SLIM TIP, MODEL: MN10450-50A, UDI: (B)(4), SERIAL: (B)(4), BATCH: 7791320. COMMON DEVICE NAME: 50CM IMPLANT LEAD KIT, SLIM TIP, MODEL: MN10450-50A, UDI:(B)(4), SERIAL: (B)(4), BATCH: 7791320. DURING PROCESSING OF THIS INCIDENT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE PATIENT INFORMATION. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

Description of Event or Problem · 0

IT WAS REPORTED THE PATIENT EXPERIENCED INADEQUATE STIMULATION WITH THEIR SCS SYSTEM. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2023 WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED. IT IS UNKNOWN WHICH LEAD IS LIABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
685473	KIT IMPLANTABLE SLIM TIP LEAD, 50CM	DRG SLIM TIP LEAD	PMP	ABBOTT MEDICAL	MN10450-50A	7791320	05415067027153

Patients

Seq	Age	Sex	Outcome	Treatment
1		Male	Other	DRG IPG\| SCS LEAD (3)