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

Model Number	SC-3138-25
Medical Device Problem Codes	Fracture (1260); High impedance (1291)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-extension, upn: (b)(4), model: sc-3138-25, serial: (b)(4), batch: 1091426 / 1102581 / 1103419.
Event or Problem Description
It was reported that the patients lead extensions had high impedances.The patient underwent an explant procedure and was reprogrammed.Th patient was doing well postoperatively and the high impedances were cleared.The explanted devices will be returned.
Additional Manufacturer Narrative
Sc-3138-25 (sn: (b)(6)) the returned lead extension was analyzed and indicated the complaint of the impedance anomalies was confirmed.The proximal end connector was fractured where two cables were electrically open.The lead was most likely exposed to excessive mechanical force when it was inserted into the ipg port resulting in the fractured proximal array and damaged cables.Sc-3138-25 sn: (b)(6).The returned lead extension was analyzed and indicated that two cables were fractured close to the proximal array.The device failed the impedance measurement test.Sc-3138-25 sn: (b)(6).The returned lead extensions were analyzed, passed all tests performed, and exhibited normal device characteristics.
Event or Problem Description
It was reported that the patients lead extensions had high impedances.The patient underwent an explant procedure and was reprogrammed.The patient was doing well postoperatively and the high impedances were cleared.The explanted devices will be returned.

• Brand Name: PRECISION
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 10131506
• Report Number: 3006630150-2020-02380
• Device Sequence Number: 2823576
• Product Code: LGW
• UDI-Device Identifier: 08714729760542
• UDI-Public: 08714729760542
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/04/2021
• Device Model Number: SC-3138-25
• Device Catalogue Number: SC-3138-25
• Device Lot Number: 7059434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Initial Date Received by Manufacturer: 05/19/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR