MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LINEAR ST; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number SC-2218-50

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2218500, model: sc-2218-50, serial: (b)(4), batch: 19013108/19013108.

Event Description

It was reported that during an ipg replacement procedure (mfr.Report no.3006630150-2021-02483), the physician was unable to get one of the leads in the new ipg as it had a contact on the end of it that was peeling up.The lead was explanted and the other remaining leads were reimplanted.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-2218-50 (sn (b)(6)): the returned lead was analyzed and indicated that the proximal end was deformed and it failed the dimensional test (proximal go/no).The spacer between contact #3 and #4 of the proximal tip has bulged and it resulted in the inability to in and out of the ipg port.The deformation was due to the age of the old lead and it was being reused during the ipg swap.With all the available information, boston scientific concludes that he complaint was confirmed.The proximal array most likely got bent during the procedure.Hence, the probable cause selected for this complaint.

Event Description

It was reported that during an ipg replacement procedure (mfr.Report no.3006630150-2021-02483), the physician was unable to get one of the leads in the new ipg as it had a contact on the end of it that was peeling up.The lead was explanted and the other remaining leads were reimplanted.The patient was doing well postoperatively.

• Brand Name: LINEAR ST
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 11904651
• MDR Text Key: 254279993
• Report Number: 3006630150-2021-02495
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: 08714729767725
• Combination Product (y/n): N
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2018
• Device Model Number: SC-2218-50
• Device Catalogue Number: SC-2218-50
• Device Lot Number: 19013108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2021
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 06/16/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR