MAUDE Adverse Event Report: MPRI ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number	3387S-40
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Receipt by User (1570)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative (rep) via a healthcare professional (hcp) regarding a patient implanted with a neurostimulator (ins) for dystonia and movement disorders.It was reported that a new lead was opened and contact 0 was bent out of box.The surgeon would not implant the lead, so a new lead was used.The bent lead never touched the patient.The issue was resolved at the time of this report.No further complications are anticipated.
Additional Manufacturer Narrative
Analysis of the lead (lot# va1fuq8) found that the tip of the lead was bent at the #0 electrode sleeve on the distal end.Additional analysis results: product analysis #(b)(4):analysis information -- (b)(6)2017, 15:19:16 cst pli# 10 product id# 3387s-40 analysis confirmed that the distal end of the lead was bent.{electrical testing of the lead determined that continuity was comple te and no electrical shorts were observed between circuits.} electrical testing of the lead determined continuity was complete and no electrical shorts were identified between the circuits.Analysis observed the distal end of the lead was bent.{the tip of the lead was bent at the #0 electrode sleeve.} concomitant product(s): product id :neu_stylet_acc, lot# unknown, product type: accessory.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ACTIVA
• Common Device Name: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 6537100
• Report Number: 2649622-2017-04893
• Device Sequence Number: 19242848
• Product Code: MRU
• UDI-Device Identifier: 00643169516540
• UDI-Public: 00643169516540
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: H020007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2019
• Device Model Number: 3387S-40
• Device Catalogue Number: 3387S-40
• Device Lot Number: VA1FUQ8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2017
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; 06/29/2017; 06/29/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 06/08/2017; 06/22/2017; 06/29/2017; 10/03/2017; 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR