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

Model Number SC-1110-02

Device Problems Unexpected Therapeutic Results (1631); Device Inoperable (1663); Charging Problem (2892)

Patient Problems Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2017

Event Type  Injury  

Event Description

A report was received that the patients ipg was non-functional.The patient will undergo an ipg replacement procedure.

Manufacturer Narrative

Additional information was received that no further course of action will be taken at this time.

Event Description

A report was received that the patients ipg was non-functional.The patient will undergo an ipg replacement procedure.

Manufacturer Narrative

Additional information was received that the patient also had inadequate stimulation.The patient underwent an ipg replacement procedure.The explanted device was not returned to bsn as it was kept by the medical facility.It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed. a review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

A report was received that the patients ipg was non-functional.The patient will undergo an ipg replacement procedure.

• Brand Name: PRECISION
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25129 rye canyon loop; ,; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; ,; valencia, CA 91355 ; 6619494863
• MDR Report Key: 7553557
• MDR Text Key: 109545363
• Report Number: 3006630150-2018-01924
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767688
• UDI-Public: 08714729767688
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2019

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: 03/31/2012
• Device Model Number: SC-1110-02
• Device Catalogue Number: SC-1110-02
• Device Lot Number: 198574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2018
• Initial Date FDA Received: 05/30/2018
• Supplement Dates Manufacturer Received: 06/07/2018; 12/19/2018
• Supplement Dates FDA Received: 06/28/2018; 01/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR